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- Title
Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial.
- Authors
Choi, Ki Hong; Park, Taek Kyu; Song, Young Bin; Lee, Joo Myung; Lee, Jong-Young; Lee, Seung-Jae; Lee, Sang Yeub; Kim, Sang Min; Yun, Kyeong Ho; Cho, Jae Young; Kim, Chan Joon; Ahn, Hyo-Suk; Yoon, Hyuck-Jun; Park, Yong Hwan; Lee, Wang Soo; Jeong, Jin-Ok; Song, Pil-Sang; Doh, Joon-Hyung; Jo, Sang-Ho; Yoon, Chang-Hwan
- Abstract
This secondary analysis of a randomized clinical trial examines the occurrence of target vessel failure and the role of diabetes in the clinical outcomes of patients undergoing complex percutaneous coronary intervention. Key Points: Questions: Is the benefit of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) different in the presence of diabetes? Findings: In this prespecified secondary analysis of a subgroup of 1639 participants in the RENOVATE-COMPLEX-PCI randomized clinical trial, intravascular imaging guidance reduced the risk of target vessel failure compared with angiography guidance in patients without diabetes but not in patients with diabetes during complex PCI. Among patients with diabetes, only those with good glycemic control and who achieved stent optimization by intravascular imaging had a lower risk of future ischemic events. Meaning: Findings of this study suggest that in patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging as well as glycemic control to improve outcomes. Importance: Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes. Objective: To compare the clinical outcomes of intravascular imaging–guided vs angiography-guided complex PCI in patients with or without diabetes. Design, Setting, and Participants: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging–guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024. Interventions: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Results: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P <.001). Among patients without diabetes, the intravascular imaging–guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P <.001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P =.90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction =.02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P =.02). Conclusions and Relevance: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872
- Subjects
SOUTH Korea; MYOCARDIAL infarction; RISK assessment; SECONDARY analysis; RESEARCH funding; DATA analysis; OPTICAL coherence tomography; GLYCEMIC control; ULTRASONIC imaging; TREATMENT effectiveness; DESCRIPTIVE statistics; SURGICAL stents; MYOCARDIAL revascularization; KAPLAN-Meier estimator; LOG-rank test; PERCUTANEOUS coronary intervention; STATISTICS; CORONARY angiography; CARDIAC arrest; CORONARY artery disease; CONFIDENCE intervals; DATA analysis software; DISEASE incidence; PROPORTIONAL hazards models; REGRESSION analysis; DISEASE risk factors
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2417613
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.17613